1. Field of the Invention
This invention relates to medical devices used in irrigating and cleansing wound sites on patients, and is specifically related to splash shields for preventing the back splash of fluids from a wound during wound irrigation so that the wound fluids do not contact the attending medical caregiver.
2. Statement of the Art
It is well-known that wounds to the body which occur through injury or accident, through surgical procedure, or which are caused by compromised circulation, such as pressure ulcers, must often be cleansed to keep the wound free of bacteria and other deleterious matter which may compromise the rate at which the wound heals. Cleansing of the wound often involves irrigating the wound with a stream or spray of liquid, such as isotonic saline or other sterile solution. Current clinical practice guidelines indicate that an irrigation pressure of between four to fifteen pounds per spare inch is effective for the cleansing of pressure ulcers or other chronic wounds. That amount of pressure is sufficient for removal of foreign particles, debris and bacteria to thereby promote healing and minimization of infection or inflammation, yet low enough to avoid or minimize damage to regenerating granulation tissue in the wound. The guidelines also recommend the use of high pressure irrigation for mechanical debridement to remove the devitalized tissue.
Delivery of the irrigating liquid to the wound site is usually accomplished by pumping liquid from a hypodermic syringe through an attached needle, or catheter, trained toward the wound site. Most of the liquid delivered to a wound site flows away from the wound site and is usually collected in some manner, such as in a bowl or with absorbent material. However, some back splash of fluid and debris from the wound occurs, especially at higher pressures of liquid delivery. The liquid back splash contains not only irrigating liquid, but fluid from the wound and loose matter extracted from the woundxe2x80x94particularly in situations where wound irrigation is conducted for debridement of the wound. It is unpleasant and potentially dangerous to have the back splash liquid from the wound strike the medical personnel conducting the irrigation procedure or the patient, or to have the material contaminate the environment. Current OSHA guidelines regarding blood-borne pathogens require the minimization of the splatter and splashing of blood and the creation or aerosols containing potentially contaminated body fluids. Therefore, shield devices have been developed in the art to protect the caregiver from being exposed to the back splash.
Examples of wound irrigating back splash shields are disclosed in U.S. Pat. No. 4,692,140 to Olson, U.S. Pat. No. 4,669,003 to Stamler, U.S. Pat. No. 4,989,588 to Roberts, U.S. Pat. No. 5,224,940 to Dann, et al., U.S. Pat. Des. No. 344,133 to Stamler, U.S. Pat. Des. No. 345,016 to Stamler, U.S. Pat. No. 5,376,003 to Rizkalla, U.S. Pat. No. 5,441,174 to Sperry and U.S. Pat. No. 5,496,290 to Ackerman. Most of the shields disclosed in the referenced patents are rigid and are, therefore, unadaptable to the variation in wound shapes which occur. As a result, back splash liquid can still escape the confines of such shields. More importantly, rigid prior art shields can damage the regenerating tissue of a wound if the rigid circumferential edge of the shield is pressed against, scraped along, or otherwise contacted with the wound.
Most of the shields disclosed in the referenced patents are configured with a liquid delivery conduit which is positioned in alignment with a central longitudinal axis of the shield so that liquid delivery is strictly along that central longitudinal axis. The configuration of such devices requires the fluid delivery apparatus (i.e., typically a hypodermic syringe) to be positioned in vertical alignment with the wound to effectuate liquid delivery. The location of a wound on a patient is not always so accommodating. For example, a wound on the back of a patient who cannot be moved or rotated significantly from a supine position requires the caregiver to position himself and the irrigation device at a difficult angle to reach the wound. Furthermore, even those shields which are configured to provide a fluid conduit which is not strictly oriented along a longitudinal axis of the shield are unable to be angularly adjusted to modify the direction of liquid delivery to the wound.
Clinical practice guidelines requiring an irrigation pressure of 4 to 15 psi for the effective cleaning of wounds also impose an additional requirement for wound irrigating devices which is not addressed in prior art devices. It is left to the judgment of the caregiver to determine when and if the irrigating fluid is being delivered to the wound within the required range or pressure. The failure to irrigate the wound at the appropriate fluid pressure can adversely affect the health and healing of the wound, and ultimately the patient. The importance of proper irrigation is further complicated by the fact that some patients, such as elderly or frail patients, often have wounds that do not heal, or the tissue does not regenerate rapidly. Thus, fluid delivered at too high a pressure may compromise the healing process, and fluid deliberately delivered at a lower pressure may be inadequate for cleaning the wound.
Using conventionally known wound irrigating devices, the caregiver must depress with the thumb and fingers the plunger of a 35 cc hypodermic syringe filled with irrigating fluid and fitted with a 19 gauge needle of one and one half inches in length to produce an 8 psi delivery of irrigating fluid. That methodology assumes that all caregivers have the same degree of manual strength to depress the plunger and does not take into consideration that the caregiver""s hand tires after repeated fillings and evacuations of the syringe in a single wound irrigating episode, thereby leading to less and less pressure being applied to depression of the plunger. Another factor leading to uneven or inconsistent fluid pressure at delivery is the mechanics of hand movement leading to different pressure being applied to the plunger when the plunger is fully extended from the syringe barrel (and the thumb is displaced farther from the fingers) as opposed to when the plunger is almost fully positioned in the barrel (and the thumb is closer to the fingers). The difficulty of providing a sufficient and steady delivery of fluid to the wound site has been addressed in part by the development of different fluid delivery devices, such as spray bottles, squirt bottles, aerosol cannisters or water wands. While such devices have addressed the issue of fluid delivery to a wound site, such devices have not addressed the problem of back splash.
Thus, it would be beneficial to the art to provide a wound irrigation splash shield which is universally adaptable to all types of fluid delivery devices that are used in wound irrigation procedures, which is adaptable to the differences in wound dimension and body contour, and which provides a degree of angular adjustability to facilitate delivery of the irrigating fluid to a wound site while still providing protection from the back splash of fluid and other debris from the wound.
In accordance with the present invention, a wound irrigation splash shield is provided which is universally adaptable to fit a variety of known fluid delivery devices designed for delivering fluid to a wound site. The splash shield of the present invention comprises a three-dimensional shield configured to provide protection from back splash during wound irrigation procedures and has an adjustable fluid entry hub which is conformable or adaptable to a variety of fluid delivery devices used for delivering an irrigation fluid to a wound site. The splash shield is structured to be at least partially flexible to provide selective angular positioning of the hub, and thus a fluid delivery device attached to the hub, to selectively direct fluid to the wound site.
The shield of the present invention may generally be hemispherical in shape, has a peripheral edge which is positionable near or against the patient""s body and has a substantially continuous dome-like surface extending upwardly from the peripheral edge. The peripheral edge, in lateral cross section, may be circular, oval, oblong or any other suitable shape. The shield member is formed at least partially of a flexible or compliant material which renders the shield member conformable to any shape or dimension of a wound and renders it conformable to the topography of the body. In those embodiments where the shield member is only partially made of a flexible material, the flexible or compliant portion is located near the peripheral edge of the shield member and the less flexible, or comparatively rigid, portion of the shield member is located away from the peripheral edge. Thus, the peripheral edge, in any embodiment of the invention, is flexible so that it can be manipulated to be formed about the unique shape or dimension of the wound and the body""s contour and, more importantly, so that if the shield should come in contact with the wound, it will flex and not damage the tender tissues of the wound.
The shield may be structured in any suitable manner to be flexible at the peripheral edge, but substantially inflexible or comparatively rigid in other regions of the shield. The shield may then, for example, be formed by varying the thickness of the material from near the apex of the shield to the peripheral edge, by fabricating the shield from materials having a different modulus of elasticity, by removing plasticizers from the material of the shield in the area where increased stiffness or rigidity is desired, by adding plasticizers in areas where flexibility is desired or by using reinforcing longitudinal ribs incorporated into the material or structure of the shield.
The peripheral edge of the shield member may be planar (i.e., every point along the entire peripheral edge contacts a planar surface) to contain more back splash liquid in the shield, or the peripheral edge may be non-linear, such as being scalloped, to allow fluid to exit between the peripheral edge of the shield member and the patient""s skin. Additionally, at least one aperture may be formed through the surface of the shield member to allow fluid displacement or release of fluid from the shield. In accordance with one aspect of the invention disclosed herein, the shield may be structured with a peripheral edge which is planar, thereby rendering the peripheral edge capable of encircling the wound site and preventing fluid from escaping between the patient""s skin and the peripheral edge, and is further structured with a drain tube formed in the shield member near the peripheral edge and extending away from the shield member to direct irrigation fluid and fluids or debris from the wound site away from the shield member. The drain tube may be any suitable length and may be configured to extend to a receptacle for collecting the drained fluid or may be configured for attachment to a conventional medical suction device. As also disclosed herein, the drain tube may be attachable to the shield by an adapter collar or the like.
The shield of the invention may, in one embodiment, be wholly flexible throughout the structure, thereby providing the greatest degree of manipulation of the shield to fit the shape or dimension of the wound and the contour of the body. The shield of the invention, in another embodiment, may be partially flexible and partially inflexible or comparatively rigid. In either embodiment, the shield is structured with a circumferentially-adjustable hub configured to receive the end portion of any variety of fluid delivery devices. By xe2x80x9ccircumferentially-adjustable,xe2x80x9d it is meant that at least the internal diameter of the hub may be modified in some fashion to accommodate the unique diameter of the fluid-dispensing end portion or tip of any irrigation fluid delivery device. Fluid devices that may be received by the adjustable hub include any conventional device specifically designed for delivering an irrigation fluid to a wound site and any fluid delivery device that may be suitably adaptable to the purpose of delivering an irrigation fluid to a wound site. Conventional irrigation fluid delivery devices include, but are not limited to, spray bottles (e.g., Sea-Clens(trademark) manufactured by Sween Corp., Mankato, Minn.), water wands (e.g., The Water Pik-(trademark) manufactured by Teledyne, Fort Collins, Colo.), squeeze bottles (e.g., the Squirt Cap(trademark) manufactured by Baxter, Chicago, Ill.), syringes, aerosol cannister, atomizers and water pistols.
The circumferentially-adjustable hub may be configured in any manner which will enable the hub to attach to and secure the fluid-dispensing end portion, or other suitable portion, of a fluid delivery device of any given type or construction. For example, the adjustable hub may be formed as a flexible throat extending outwardly from the surface of the shield, the flexible throat being sufficiently elastic to expand to the diameter and geometry of the fluid-dispensing end portion of the fluid delivery device to thereby engage it. In an alternative embodiment, the adjustable hub may be configured as a flexible collar having an inner circumferential surface which is adjustable to expand or enlarge to engage the end portion of a fluid delivery device. In yet another alternative embodiment, the adjustable hub may be formed with an eccentric, rotatable cuff which secures the hub to the fluid-dispensing end portion of a fluid delivery device. The adjustable hub is preferably configured with an opening which is expandable enough to secure the end portion of a fluid delivery device, but which is also structured to prevent the end portion or tip of any such fluid delivery device from extending too far into the interior of the shield, thereby preventing the tip or end of the fluid delivery device from coming in contact with the wound site.
The adjustable hub of the shield member may be located at the center or apex of the shield member. Alternatively, the adjustable hub may be located away from the center or apex of the shield so that the fluid is delivered to the wound site at an angle to a longitudinal axis oriented perpendicularly to the plane of the peripheral edge of the shield member. Regardless of the placement or positioning of the adjustable hub relative to the body of the shield, the area of the shield member immediately surrounding the adjustable hub is structured to allow the hub to be angularly repositioned relative to the shield member so that the angle of the liquid moving through the adjustable hub may be selectively modified. By so configuring the shield member, the angle at which irrigating liquid is delivered to the wound site may be selected in accordance with the unique requirements of the wound (e.g., shape, depth, dimension, sensitivity). That is, some wounds are shallow and the tissues are delicate so that delivery of liquid in a directly vertical orientation to the wound, particularly at higher pressures, may cause tearing of the delicate tissues. Delivering liquid at an angle to the wound is less traumatic to the tissues, even at elevated pressure levels, and modifying the direction or angle of the spray insures that the entire area of the wound can be bathed with irrigation fluid at a desired pressure. It may be particularly suitable to form the shield member with angle indicia near the adjustable hub to direct the user in appropriately modifying the angle of the spray.
The features of the shield of the present invention are more fully understandable when considered in connection with the following description of the illustrated invention.